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Mended Hearts groups launch ASD awareness campaign with atHeart Medical

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US patient support groups Mended Hearts and Mended Little Hearts launched an awareness campaign on atrial septal defects (ASDs) thanks to an unrestricted educational grant by atHeart Medical.

The campaign provides patients and families of children with ASDs with information on symptoms and treatment options, including a downloadable discussion guide to prepare for health visits and an educational video featuring interventional cardiologist Scott Lim, MD, from University of Virginia.

“Like most congenital heart defects, ASDs deeply affect the lives of those born with them. We work to inspire hope and improve the quality of life of heart patients and their families through ongoing support, education and advocacy,” said Denise Duch Widzgowski, Mended Hearts President. “We are grateful to partners like atHeart Medical for enabling us to pursue our mission.”

ASDs are a congenital heart defect (CHD) and make up for 5 to 10 percent of all heart problems babies can be born with. It is important to treat an ASD as early as possible to prevent heart failure, stroke, lung problems, valve problems, and arrhythmias. Treatment will depend on the ASD size, the severity of symptoms and patient’s age.

“As a young company, we are incredibly proud to support the fabulous work that the Mended Hearts group conducts for patients in the USA, nationwide and chapter by chapter. Information, education and support can make the difference in patients’ lives and choices,’ said atHeart Medical CEO Laurent Grandidier.

View the ASD awareness information and materials on Mended Hearts website

ASCENT ASD trial started Stage 3 enrollment, following US and EU regulatory authorization

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The ASCENT ASD pivotal trial of atHeart Medical’s reSept ASD occluder has advanced to Stage 3 enrollment, following regulatory authorization of trial expansion by the US Food and Drug Administration (FDA) and by the French National Agency for Medicines and Health Products Safety (ANSM).

The positive decisions of the regulatory authorities followed the review of data from the first 50 US and EU patients, as part of the initial stages of this ongoing trial.

“Our team is delighted to progress with patient enrollment following the green light from the FDA and ANSM. We are committed to demonstrate that ASDs may be effectively closed without jeopardizing cardiovascular treatments that patients may need in the future,” said CEO Laurent Grandidier.

ASCENT ASD is a prospective, single-arm study evaluating the safety and efficacy of the reSept™ ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD occluders. The trial is aiming to enroll a total of up to 250 patients.

View which US and EU hospital sites are actively recruiting patients in the ASCENT ASD trial here

Meet our new VP R&D NextGen

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Vice-President Fabien Lombardi recently joined atHeart Medical to lead the R&D team driving forward next generation devices. He boasts a comprehensive background in project management, spanning across various facets from materials to the development of products.

“We are thrilled to benefit from Fabien’s forward-thinking mindset and strategic technical planning,” said atHeart Medical’s CEO Laurent Grandidier. “His successful track record of 20+ years in medical device development and leadership is a great asset for the evolution of atHeart Medical’s future devices.”

Prior to atHeart Medical, Fabien held leadership roles at startups in structural heart devices and biomaterials and at well established companies across multiple European countries, Australia and the United States.

“I am thrilled to be part of atHeart Medical’s extraordinary team and of a very ambitious program to ultimately improve the life of people with structural heart issues,” Fabien said.

View all team’s bios here

Children’s Heart Awareness Day

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On 5th of May, it is Children’s Heart Awareness Day in Switzerland. As a Swiss/American company, we want to mark this day to remember when most heart journeys begin: during infancy and childhood.

In Switzerland, a child is born with a heart defect every hundred births.  Although some heart defects resolve over time, more severe ones may require interventions, in childhood and later in life.

We are very mindful of our purpose, to help find better solutions for children and adults born with atrial septal defects. With our work, we endeavour to ease their heart journey, to help reduce the need for interventions and to keep more treatment options open for their future.

1200 gloves for a hospital in Ivory Coast

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The Dabou Hospital in Ivory Coast is currently using 1200 new, sterile medical gloves donated by atHeart Medical. It is thanks to the long-standing work done by the Ruedi Leuppi Foundation, a Zug-based charity working in Ivory Coast, and the relentless problem-solving approach of our VP of Operations, Alex Goehring, that we managed to ship in no time a significant supply of gloves where they would be mostly needed.

Swiss clinician Dr Leuppi has been cooperating with the Dabou Methodist Hospital since 2004. He established the first urology department onsite and is spending several weeks on multiple trips each year to provide materials and donations, and to train local healthcare professionals.

“We are happy to accept material (medicine, laboratory, training) as long as it is still in good condition. Even used material from Switzerland here in Dabou is indispensable work material to serve patients,” Dr Lueppi explained.

“Two days after establishing contact, Dr Leuppi came to collect the equipment, which few days later was already in a container on its way to Africa,” said Alex. “It was a fantastic team effort to preserve valuable medical equipment, which needed replacement due to changes in our production process, and to put it to good use to treat human lives.”

To learn more or to donate to the Leuppi Foundation, please click here

The ASD closure that started Ella’s best life

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Ella suffered from migraine and severe fatigue as a teenager and now has a new life at college following her ASD closure, as part of the ASCENT ASD trial. Her uplifting story has been reported in Advance With MUSC Health, the online blog by Medical University of South Carolina (MUSC), the ASCENT-ASD trial center where her procedure was performed.

In the article entitled “Undoing Ella’s suffering”, her mother and treating clinicians recall how her impairing ASD symptoms have been misdiagnosed and mistreated during her teenage years, leaving her sleeping through school. It was her mother’s sixth sense and determination that eventually triggered the right diagnosis and treatment by cardiologist John Rhodes at MUSC.

About joining a trial for a novel ASD occluder device, Ella said: “I was pretty excited. I liked the idea of it, something new and innovative. I really didn’t have any hesitations about it.” Overall, Ella’s symptoms have improved since her procedure in March 2022, states the article.

“Ella is excited to be going to school in Charleston, to be a part of the study and close to Dr Rhodes,” said her mother Erica. “She feels so much better having gotten the procedure done. I’m delighted she’s so happy. Ella is a different person, living her best life.”

For the full article, please click here

reSept in Congenital Cardiology Today

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The reSept ASD Occluder is featuring as a potentially ideal treatment approach for Atrial Septal Defects (ASDs) in an extensive article by Professor Thomas K Jones, Senior Congenital Interventional Cardiologist Seattle Children’s Hospital, in the latest issue of Congenital Cardiology Today.

The article entitled “The Bioresorbable reSept™ ASD Occluder: Moving Closer to the Ideal” covers in remarkable detail the history and latest progress in Atrial Septal Defects treatment, from the very first open-heart operation in 1954 to today’s ongoing clinical trial of atHeart Medical’s reSept ASD Occluder.

According to Professor Jones, “interventional cardiologists have expressed a need for ASD occluders to be bioresorbable. The ability of the rigid framework of an occluder to be gradually reabsorbed during the healing response was identified as a highly desirable attribute by key opinion leaders and the pioneers of transcatheter ASD occlusion since 1990”.

The article illustrates the inclusion and exclusion criteria of the FDA-approved clinical study ASCENT ASD trial and lists the 19 participating centers in the USA and in France.

For the full article, please click here

reSept ASD Occluder implanted in EU for the first time

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French TV France3 reported on the first patients implanted with a reSept ASD Occluder in France and in the European Union at Bordeaux University Hospital. The coverage includes video interviews with young patient Léo and his mother, and with the doctors that treated him, as part of the ASCENT ASD trial.

Professor Jean-Benoît Thambo, head of the department of pediatric and congenital cardiology at the Bordeaux University Hospital, said to France3 how “these prostheses are the first phase of the medicine of tomorrow, a medicine that opts for material adapted to the body, biological”.

As interventional cardiologist Zakaria Jalal explained to France3, “with time and healing, the components of the prosthesis will be digested by the body, the patient will eventually carry very few foreign bodies within his body.”

The successful procedure is reported to have lasted for fifteen minutes and that Léo was expected to return home the next day.

The investigational reSept ASD Occluder is also being studied in the US under an FDA approved protocol.

For the English translation, click here

For the original article in French, click here

For the original video interview in French, click here

FDA Approved Second Phase of ASCENT ASD

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atHeart Medical has received approval for the start of the second phase of its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial.

The prospective, single-arm study is evaluating the safety and efficacy of the reSept ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD occluders.

“I am pleased the first phase of enrollment in our pivotal trial progressed smoothly and according to plan, this is an exciting milestone for the company,” said Laurent Grandidier, CEO of atHeart Medical. “As we initiate the second phase, our team is focused on adding clinical sites across the U.S. and expanding internationally to include several enrolling sites in France. I commend the team’s diligence to further validating the safety and efficacy of the reSept ASD Occluder, a critical step in our journey to evolve septal closure and provide a better solution for patients.”

Read full press release

Mathilda has a special heart

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The story of the first patient implanted with a reSept ASD Occluder in Switzerland has been reported in Forschungs-Magazin, the research magazine by Children’s Hospital Zurich, where Mathilda’s intervention took place.

In a heartfelt recollection, Mathilda’s family shared their journey from diagnosis, through to coronavirus and travel restrictions, to the operation with a novel device with a metal-free frame, and the welcomed, normal life that followed. “Once she got back home, there was nothing to indicate that she had just had a heart operation. Mathilda was alert and started school two weeks later,” Mathilda’s mother remembered in the article.

Forschungs-Magazin also interviewed Professor Oliver Kretschmar, Chief Physician and Co-Head of the Cardiology Department at the University Children’s Hospital Zurich, and Professor of Paediatric Cardiology at the University of Zurich, who implanted Mathilda.

Professor Kretchmar explained in the magazine how minimally invasive implants tend to be ideal options for young patients. “The best implant is not an implant. If it fulfils its purpose, closes the hole and then largely dissolves and the body’s own tissue grows over the hole, that’s fantastic,” he stated.

Read the English translation of the article

Read the original article in German